Effect of Electrical Stimulation (DC Polarization) to the Brain on Memory

NCT00471107 | Completed Phase 1 Results

• 2 other identifiers: 07014707-N-0147
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effect of direct current (DC) brain polarization (the application of a very weak electrical current to the brain) on learning and memory. Earlier studies have shown that DC polarization can temporarily improve the ability of healthy people to think of certain words. This study will explore whether it can also temporarily improve learning and memory. Healthy people 18 years of age and older may be eligible for this study. Subjects participate in two experimental sessions at the NIH Clinical Center. The first session lasts about 1 hour; the second session, on the next day, takes about 10 minutes. At the beginning of the first session, electrodes are placed on the subject's head and arm for brain stimulation. The current may be turned on for 25 minutes, or only very briefly (sham stimulation). Subjects are not told which type of stimulation they are receiving. No stimulation is applied in the second session. During the sessions subjects are asked to complete the following tasks that will help elucidate the effects of polarization:

• Read a list of words and remember them. Later they will try to repeat the words from memory.
• Look at a series of designs and remember them. Later they will try to draw the designs from memory.
• Push a button on a keyboard when they see a specific item (for example, when the number 7 appears).
• Generate as many words as they can think of that begin with a particular letter of the alphabet. Subjects may be videotaped for some or all of the time during the sessions.

Conditions

Healthy

Keywords

Frontal Lobe; Language; Dementia; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Verbal Memory

  The Wechsler Memory Scale (WMS-III) is a neuropsychological test designed to measure different memory functions. The WMS-III Word Lists is a measure of verbal learning ability. The examiner reads a list of 12 semantically unrelated words and the subject immediately recalls as many words as possible. For this study, the primary outcome is a measure of verbal recall performance at 24 hours following presentation of the words under three conditions, i.e., anodal tDCS, cathodal tDCS, and sham. Scores may range from 0 (no words recalled) to 12 (all words recalled).

  24 hours

Study Arms (3)

Sham TDCS

SHAM COMPARATOR

Device: DC brain polarization

Surface-anodal direct current

EXPERIMENTAL

0.08 mA/cm2

Device: DC brain polarization

Surface-cathodal direct current

ACTIVE COMPARATOR

0.08 mA/cm2

Device: DC brain polarization

Interventions

DC brain polarization DEVICE

0.08 mA/cm2

Sham TDCS; Surface-anodal direct current; Surface-cathodal direct current

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any history of a central nervous system illness or other behavioral disorder.
• Broken skin in the area of the electrodes.
• Uncontrolled medical problems, such as diabetes mellitus, hypertension, airway disease, heart failure, coronary artery disease, or any other condition that poses a risk for the subject during participation.
• Presence of metal in the cranial cavity.
• Holes in the skull made by trauma or surgery.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Herwig U, Satrapi P, Schonfeldt-Lecuona C. Using the international 10-20 EEG system for positioning of transcranial magnetic stimulation. Brain Topogr. 2003 Winter;16(2):95-9. doi: 10.1023/b:brat.0000006333.93597.9d.

  PMID: 14977202 BACKGROUND

• BINDMAN LJ, LIPPOLD OC, REDFEARN JW. Long-lasting changes in the level of the electrical activity of the cerebral cortex produced bypolarizing currents. Nature. 1962 Nov 10;196:584-5. doi: 10.1038/196584a0. No abstract available.

  PMID: 13968314 BACKGROUND

• CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.

  PMID: 13882165 BACKGROUND

MeSH Terms

Conditions

Language; Dementia

Condition Hierarchy (Ancestors)

Communication; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Eric Wassermann
• Organization: NIH/NINDS

wassermanne@ninds.nih.gov

301-496-0151

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 24, 2016
• Results First Posted: May 15, 2013

Record last verified: 2013-03

Locations

US (1)